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NCT Number: NCT06576661

Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes

The goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons' behavior during ureteroscopy while using the ureteroscope LithoVue Elite.

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Key information

Conditions

Kidney Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Location contact

Jane Ledesma, BS

CONTACT

[email protected]

913-588-8721

About this study

Despite advances in surgical techniques and technology, preventable adverse events still occur in the operating room, with half of them attributed to poor non-technical skills of surgical teams. Therefore, it is essential to observe and measure surgeons' intraoperative non-technical skills and provide structured feedback to improve patient safety. The new LithoVue Elite™ disposable ureteroscope has the potential to impact surgeons' behavior during ureteroscopy, as it enables the measurement of real-time intrarenal pressures. The study is designed to evaluate urologists' behavior during ureteroscopic stone treatment with and without intra-renal pressure monitoring.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females over 18 years of age
  • Undergoing flexible ureteroscopy to address urinary stones located in the proximal ureter or kidney
  • Total stone burden over 2 cm

Exclusion criteria

  • Undergoing bilateral stone treatment during the same procedure
  • Patients with known genitourinary anatomical abnormalities
  • Uncorrected coagulopathy
  • Patients with urinary diversions
  • Chronic external urinary catheters
  • Women who are pregnant
  • Immunosuppressed patients

Treatment and study plan

INTRARENAL PRESSURE MONITORING VISIBLE

Device

In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™.

Primary outcomes

  1. Surgeon behavior as measured by mean Non-Technical Skills for Surgeons (NOTSS) score.

    Time frame: Procedure

    Treating investigators will be evaluated using the modified NOTSS tool during the procedure. The NOTSS is used to measure non-technical skills in the operation room in the following categories; situation awareness, decision making, communication & teamwork, and leadership.

Secondary outcomes

  1. Difference in decision-making domain scores as measured by the Non-Technical Skills for Surgeons (NOTSS) scores

    Time frame: Procedure

    Treating investigators will be evaluated using the modified NOTSS tool during the procedure. The NOTSS is used to measure non-technical skills in the operation room in the following categories; situation awareness, decision making, communication & teamwork, and leadership.

  2. Post-operative infection

    Time frame: 30-days post-operative

    Patient signs and symptoms concerning for a urinary tract infection, along with a positive urine culture

  3. Perioperative patient outcomes as measured by Clavien-Dindo classification system

    Time frame: Up to 30 days

    Intraoperative complications will be categorized based on the Clavien-Dindo classification system

  4. Post-operative pain as measured by Visual analog scale (VAS)

    Time frame: Immediately post-operative and up to 7 days

    The VAS is a valid and reliable method for quantifying pain intensity on a scale of 0 to 10, where 0 represents no pain and 10 represents the most severe pain possible.

  5. Post-operative pain as measured by opioid use

    Time frame: Immediately post-operative and up to 7 days

    Opioid usage will be tracked

Study contacts

Contact information is provided by the study sponsor or research team.

Jane Ledesma

CONTACT

[email protected]

19135888721

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: ELITE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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